Systems, devices and methods for stabilizing bone

Abstract

Described herein are devices, systems, and methods for treating bone, particularly for restoring bone dimension in compression fractures. Self-expanding stabilization devices for repairing bone may include two or more continuous curvature of bending struts that extend from a central shaft in the deployed configuration. The stabilization device may be attached to an inserter. An inserter may be used to hold the stabilization device in a collapsed delivery configuration so that it can be inserted into bone. In use, the stabilization device may be part of a system or kit for installing the device into a bone region and allowing it to expand to correct a bone fracture.

1 . A stabilization device configured to self-expand from a compressed delivery configuration to an expanded deployed configuration, the stabilization device comprising:
 an elongate shaft having two or more continuous curvature of bending struts, wherein the struts extend from the shaft more in the deployed configuration than in the delivery configuration;   a proximal region having a first releasable attachment configured to attach to an inserter; and   a distal region having a second releasable attachment configured to attach to the inserter.   
     
     
         2 . The device of  claim 1 , further comprising two or more slits in the elongate shaft. 
     
     
         3 . The device of  claim 2 , wherein the struts are formed by two or more slits. 
     
     
         4 . The device of  claim 1 , wherein the struts are formed of a shape memory alloy. 
     
     
         5 . The device of  claim 3 , wherein the shape memory alloy is Nitinol. 
     
     
         6 . The device of  claim 1 , wherein the first releasable attachment comprises an L-shaped notch. 
     
     
         7 . The device of  claim 1 , wherein the first releasable attachment comprises a threaded region. 
     
     
         8 . The device of  claim 1 , wherein the second releasable attachment comprises an L-shaped notch. 
     
     
         9 . The device of  claim 1 , wherein the maximum distance between the struts at a point along the length of the shaft in the expanded deployed configuration is between about 0.5 and about 30 mm. 
     
     
         10 . The device of  claim 1 , wherein the maximum distance between the struts at a point along the length of the shaft in the expanded deployed configuration is between about 8 and about 20 mm. 
     
     
         11 . The device of  claim 1 , wherein the maximum distance between the struts at a point along the length of the shaft in the expanded deployed configuration is about 10 mm. 
     
     
         12 . The device of  claim 1 , wherein the maximum distance between the struts at a point along the length of the shaft in the expanded deployed configuration is about 18 mm. 
     
     
         13 . A self-expanding stabilization device for stabilizing a body cavity, the device comprising:
 an elongate shaft having a plurality of continuous curvature of bending struts extendable therefrom, the shaft adapted to be positioned within cancellous bone and having an expanded deployed profile and a collapsed delivery profile;   a proximal region configured to releasably connect to a first portion of an inserter;   a distal region configured to releasably connected to a second portion of an inserter;   wherein the shaft is adapted to cut through cancellous bone during expansion from the collapsed delivery profile to the expanded deployed profile; and   further wherein the shaft is adapted to abut a surface of cortical bone adjacent the cancellous bone without passing there through.   
     
     
         14 . An inserter for inserting a stabilization device, the inserter comprising:
 a first elongate member having a first stabilization device attachment region that is adapted to releasably attach to the proximal region of the stabilization device; and   a second elongate member having a second stabilization device attachment region that is adapted to releasably attach to the distal region of the stabilization device;   wherein the second elongate member is axially movable relative to the first elongate member.   
     
     
         15 . The inserter of  claim 14 , wherein the first elongate member and the second elongate member are configured so that they may be independently rotated axially with respect to each other. 
     
     
         16 . The inserter of  claim 14 , wherein the first stabilization device attachment region comprises a pin configured to mate with a channel in the proximal region of the stabilization device. 
     
     
         17 . The inserter of  claim 14 , wherein the second stabilization device attachment region comprises a pin configured to mate with a channel in the distal region of the stabilization device. 
     
     
         18 . The inserter of  claim 14 , further comprising a handle. 
     
     
         19 . The inserter of  claim 14 , further comprising a knob on the first elongate member. 
     
     
         20 . The inserter of  claim 19 , wherein the handle configured so that the inserter mates with the handle in a modular fashion. 
     
     
         21 . The inserter of  claim 14 , wherein the second elongate member is coaxial to the first elongate member. 
     
     
         22 . An inserter for inserting a stabilization device, the inserter comprising:
 a first elongate member having a stabilization device attachment region at the distal end, wherein the stabilization device attachment region is adapted to releasably attach to the proximal region of the stabilization device;   a second elongate member having a stabilization device attachment region at its distal end that is adapted to releasably attach to the distal region of the stabilization device,   wherein the second elongate member is axially movable relative to the first elongate member; and the first elongate member and the second elongate member are independently axially rotatable with respect to each other;   a first handle attachment region at the proximal end of the first elongate member; and   a second handle attachment region at the proximal end of the second elongate member.   
     
     
         23 . A system for stabilizing a vertebral body, the system comprising:
 a stabilization device having an elongate shaft and a plurality of struts extending therefrom, the stabilization device configured to expand from a compressed delivery configuration to an expanded deployed configuration; and   an inserter having a first stabilization device attachment region, adapted to releasably secure to the proximal region of the stabilization device, and a second stabilization device attachment region adapted to secure to the distal region of the stabilization device.   
     
     
         24 . The system of  claim 23 , further comprising an introducer. 
     
     
         25 . The system of  claim 23 , further comprising a handle. 
     
     
         26 . The system of  claim 23 , wherein the introducer further comprises a handle. 
     
     
         27 . The system of  claim 23 , further comprising a trocar. 
     
     
         28 . The system of  claim 23 , further comprising a twist drill. 
     
     
         29 . The system of  claim 23 , further comprising bone cement. 
     
     
         30 . The system of  claim 23 , further comprising a cement cannula. 
     
     
         31 . A system for stabilizing a vertebral body, the system comprising any of the stabilization devices of  claims 1 - 13  and any of the inserters of  claims 14 - 22 . 
     
     
         32 . A method of treating a bone comprising:
 delivering a self-expanding device within a cancellous bone; wherein the device has an elongate shaft and a plurality of continuous curvature of bending struts extending therefrom; and   allowing the device to expand within the cancellous bone so that a cutting surface of the device cuts through the cancellous bone.   
     
     
         33 . The method of  claim 32 , further comprising visualizing the device within the bone. 
     
     
         34 . The method of  claim 32 , further comprising drilling a hole into the cancellous bone through which the self-expanding device may be inserted. 
     
     
         35 . The method of  claim 32 , further comprising applying force to further expand the device within the cancellous bone. 
     
     
         36 . The method of  claim 32 , further comprising applying bone cement within the cancellous bone.